Adempas

Other drugs may interact with riociguat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

• Promotes vasodilation via effects on the nitric oxide-sGC-cyclic guanosine monophosphate (cGMP) pathway.1 6 7 10 Impairment of this nitric oxide signaling pathway, including decreased synthesis of nitric oxide and insufficient stimulation of sGC, demonstrated in patients with pulmonary hypertension.1 7 10 18

• Dual mechanism of action; increases sensitivity of sGC to endogenous nitric oxide and also directly stimulates sGC independent of nitric oxide, resulting in increased levels of cGMP and subsequent vasodilation.1 7 10

• In patients with pulmonary hypertension, improves hemodynamics (e.g., pulmonary vascular resistance, pulmonary artery pressure, cardiac output) and concentrations of N-terminal prohormone of brain (pro-brain) natriuretic peptide, a biomarker of heart function.1 2 3 7 15 16

• Some antiproliferative and antifibrotic effects also observed.1 2 17

Riociguat is used to treat adults with chronic thromboembolic pulmonary hypertension (CTEPH) that can be treated after surgery, or that cannot be treated with surgery.

Riociguat is also used to treat adults with pulmonary arterial hypertension (PAH), by relaxing these blood vessels and increasing the supply of blood to the lungs, which reduces the workload of the heart.

This medicine is available only with your doctor's prescription and through a special restricted distribution program called the Adempas® REMS program.

Use this medicine (Adempas) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• If you cannot swallow tablets, the tablet may be crushed and mixed with water or soft food like applesauce. Take the mixture right away. Do not store for future use.
• To gain the most benefit, do not miss doses.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.
• Do not take antacids that have aluminum or magnesium in them within 1 hour of this medicine (Adempas).
• Your dose may be changed if you have side effects.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you miss 3 days of this medicine, call your doctor to find out what to do.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Upset stomach or throwing up.
• Heartburn.
• Loose stools (diarrhea).
• Hard stools (constipation).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Other drugs may interact with riociguat, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for riociguat. The REMS consists of elements to assure safe use, an implementation system, and a medication guide. For additional information: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm

US BOXED WARNING:
-EMBRYOFETAL TOXICITY: This drug is contraindicated in pregnant women because it may cause fetal harm.
Recommendations:
-Female patients of reproductive potential must have a negative pregnancy test prior to starting treatment, monthly during treatment, and for 1 month after discontinuation of treatment. Patients should be instructed to contact their provider if they become pregnant or suspect they may be pregnant.
-Female patients of reproductive potential must use acceptable methods of contraception during treatment and for 1 month after discontinuation of treatment. Patients may choose one highly effective form of contraception (intrauterine devices [IUD], contraceptive implants, or tubal sterilization) or a combination of methods (hormone method with a barrier method or two barrier methods). If a partner vasectomy is the chosen method, a hormone or barrier method must be used also.
-Patients should be counseled on pregnancy planning and prevention, including emergency contraception.
-Patients should be counseled on the risk to the fetus.
-Females can only receive this drug through the Adempas REMS Program.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Due to its high protein binding, this drug is not expected to be dialyzable.

A decision should be made to discontinue breast-feeding or discontinue the drug, taking into account the importance of the drug to the mother. -According to some authorities, use is contraindicated. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.